Intra-procedural Transthoracic EChocardiogram to Facilitate Left Bundle Branch Area Pacing (LBBAP)
Completed · Not applicable
Conditions studied: Heart Failure
In brief
The goal of this observational study is to learn more about whether or not the use of heart ultrasound during pacemaker implantation is helpful. The main questions this aims to answer are: 1. Does this help the doctors with figuring out the wire location during implantation? 2. Does this reduce the wire placement procedure time? 3. Does this reduce the x-ray imaging time during the procedure? Participants will be asked to: 1. Have a physical exam and Echocardiogram (ECG) at initial visit, 2 weeks post implant, and 3 months post implant. 2. Have a urine pregnancy test (if applicable) 3. Have a heart ultrasound during implant procedure 4. Answer questions related to heart failure symptoms to see what stage of heart failure is present 5. Have device interrogation (a wand placed over the chest to see that the device is working properly) at a visit 2 weeks post implant and at 3 months post implant.
Key facts
- Study ID
- NCT05646251
- Run by
- Geisinger Clinic
- People needed
- 33
- Starts
- 2023-03-01
- Expected to finish
- 2024-10-27
- Last updated by the study team
- 2025-10-01
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- patient with indication for permanent pacemaker or Implantable Cardioverter Defibrillator (ICD) utilizing conduction system pacing lead for bradycardia or cardiac resynchronization therapy
- patient is willing to comply with all study procedures and be available for the duration of the study
You may not qualify if…
- Inability to provide informed consent
- pregnant
- enrolled in a concurrent study that may confound the results of this study
Where it is running
- Geisinger Clinic — Wilkes-Barre, Pennsylvania, United States
Full record on ClinicalTrials.gov
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